effectiveness of two hyaluronic acids in osteoarthritis of the knee

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to assess whether a single injection hyaluronic acid (ha) product is not inferior to a 3 injection ha product at 24 weeks (6 months), in terms of effectiveness in reducing pain when walking in patients suffering from symptomatic tibiofemoral osteoarthritis of the knee.

non-inferiority study of two ha products commercially availalble

Eligibility criteria:
inclusion criteria: * age ≥ 40 and \< 85 * tibiofemoral osteoarthritis of the knee according to the american college of rheumatology clinical criteria, in the kellgren-lawrence (kl) stages ii-iii, confirmed by radiology (\< 3 months) * unilateral symptomatic osteoarthritis of the knee causing pain when walking (womac a1 scale), assessed over the previous 24 hours on a scale of 0 to 10: pain when walking: ≤ 3 and \< 8 * bilateral osteoarthritis of the knee, if pain in the other knee is \< 3 (10-point numerical scale) * patient: outpatient, capable of walking 50 metres without a walking stick, crutches or a walker, capable of reading, understanding, signing and dating the patient information sheet * patient with social security cover exclusion criteria: * osteoarthritis of the knee in kellgren-lawrence (kl) stages i and iv * bilateral symptomatic osteoarthritis of the knee causing pain when walking (womac a1 scale), assessed on a scale of 0 to 10: pain when walking \> 3, in both knees * predominant symptomatic patellofemoral osteoarthritis of the knee * congestive manifestation of osteoarthritis of the knee defined according to the knee osteoarthritis flare-ups score (kofus) criteria * last viscosupplementation of the affected knee \< 6 months before, last injection of corticosteroids \< 2 months before * known hypersensitivity to avian proteins and hyaluronic acids; * history of joint replacement or major surgery in the affected knee in the last six months * history of arthroscopy or surgery in the affected knee in the last three months * symptomatic hip disease on the same side or other side of the body * joint replacement or any other surgery planned in the next six months * history of septic arthritis of the affected knee * skin complaint affecting the knee at the injection site * haemorrhagic disease contraindicating, in the doctor's opinion, any intra-articular injection * in order to respect the pragmatic nature of the study: * any medical and / or pathological condition that, in the investigator's opinion, makes the subject unsuitable for inclusion * any medical and / or pathological condition that, in the investigator's opinion, would be a contraindication for an intra-articular injection * any other complaint that, in the investigator's opinion, would impede the assessment of the effectiveness of the affected knee * any treatment administered to the patient that may interfere with the interpretation of the study results * use of glucocorticosteroids (except inhaled corticosteroids) during the previous month * treatment with diacerein, avocado and soya unsaponifiables, glucosamine sulphate or chondroitin sulphate, started in the previous 3 months, or irregular doses over the previous 3 months * hard of hearing (not being able to follow a telephone conversation properly) * patient without a telephone * pregnant women or nursing mothers * participation in other clinical studies, within 30 days before inclusion